540844
research-article2014
MSJ0010.1177/1352458514540844Multiple Sclerosis JournalEditorial
MULTIPLE SCLEROSIS MSJ JOURNAL
Editorial
How useful are MS registries?
Multiple Sclerosis Journal 2014, Vol. 20(11) 1423–1424 DOI: 10.1177/ 1352458514540844
Anthony Traboulsee and Katrina McMullen
© The Author(s), 2014. Reprints and permissions: http://www.sagepub.co.uk/ journalsPermissions.nav
Multiple sclerosis (MS) affects more than two million people worldwide and with a disease onset in early adulthood and long disease duration it has considerable impact on both the individual patient and on society. MS is treatable with disease modifying therapies (DMTs) but so far no cure has been identified, leading to an increasing interest in studying disease characteristics in large populations and observing long term outcomes and treatment monitoring not feasible within the time frames of clinical trials. MS registries may be able to provide this data and different registries and databases exist worldwide.1,2 In this issue of Multiple Sclerosis Journal, Flachenecker et al. present the results of a survey examining the objectives, content and structure of existing European MS registries and how they align with the European Register for MS (EUReMS) project.3,4 This project aims to build on existing registries to create a Europe-wide platform for analysis and comparison of longitudinally acquired MS data in Europe. The present survey revealed that there was a higher number of MS registries than expected (20 identified, 13 participated in the survey and 7 in the structured interview) and despite a considerable number having common objectives that cover at least some of the missions of the EUReMS project, the registries vary from country to country. Across registries, the main objectives were epidemiological research, health care research, long term therapy research and support for clinical trials whilst less frequent aims were cost effectiveness of treatment and quality management of health care. There was also considerable variety in terms of data collection (i.e. hospital versus population based), coverage, organizational structure (i.e. involvement of MS societies), documentation, quality control and governance. Further, fewer than six registries included patient reported outcomes, which have an impact on MS patients, for example employment status, fatigue, bladder/bowel dysfunction, visual disturbances and impairments in social interaction and
cognitive function. These are essential elements of understanding the progression of MS and the efficacy of treatments since clinical endpoints such as Expanded Disability Status Scale (EDSS5) scores are not fully reflective of the experience of the disease.6 Going forward, the EUReMS project aims to integrate the data from existing MS registries across Europe, setting up a standardized data architecture for future data collection and collation of information to provide data that may provide new insights into disease burden, causes and natural history of the disease, long term effectiveness of DMTs, provision of healthcare services and with the inclusion of patient reported outcomes.4
Correspondence to: Anthony Traboulsee University of British Columbia, Faculty of Medicine, Division of Neurology, 2211 Westbrook Mall, Vancouver, BC V6T 2B5, Canada. [email protected] Anthony Traboulsee Katrina McMullen University of British Columbia, Vancouver, Canada
This is an endeavour that requires an enormous amount of effort and commitment to develop, standardize and maintain. What can we hope to gain from a universal but ultimately minimal data set? Realistically we can obtain data that may answer research questions pertaining to epidemiology, healthcare resources and management, and long term efficacy and safety of prescribed treatments. However, it is naïve to assume that a large number of centres contributing to a European registry can provide more than a basic minimal data set. If the goal is to answer questions about the pathogenesis of MS then extensive environmental and genetic information for every patient is necessary but beyond the scope of the pan-European registry. The present survey results highlight that storing data in MS registries is feasible and done in many countries and the overlap between motivations, data collected and data collection methods makes sharing of this information feasible and attractive. We must be overly cautious, however, in how we share the information, in who has access to and who owns and protects the data. At a national level, this is a difficult task; at an international level, it is a gargantuan effort. So is it worth it? That depends on whether there are realistic expectations of what can be obtained from a universal basic data set and the extent
http://msj.sagepub.com 1423
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Multiple Sclerosis Journal 20(11) of participation. With extensive participation and commitment to collecting data within standardized protocols, we would have a greater ability to obtain and share information that may shed light on epidemiology, health resources and long term treatment response, aspects of MS that are not observable within the time frames or sample sizes of traditional clinical trials. The rapid increase in MS registries in the last five years reflects an attempt to answer these outstanding questions.
Visit SAGE journals online http://msj.sagepub.com
SAGE journals
Conflict of interest AT has received research support from the MS Society of Canada, Canadian Institute for Health Research, Michael Smith Foundation, holds Steering Committee membership for Hoffmann La Roche and has received consulting fees from MedImmune, Chugai, Roche, Novartis, Biogen, Teva Innovation, EMD Serono. KM has nothing to disclose.
References 1.
Flachenecker P and Stuke K. National MS registries. J Neurol 2008; 255(Suppl. 6): 102–108.
2.
Hurwitz BJ. Registry studies of long-term multiple sclerosis outcomes: Description of key registries. Neurology 2011; 76: S3–S6.
3.
Flachenecker P, Buckow K, Pugliatti M, et al. Multiple sclerosis registries in Europe-results of a systematic survey. Mult Scler 2014; [Epub ahead of print].
4.
Pugliatti M, Eskic D, Mikolcic T, et al. Assess, compare and enhance the status of persons with multiple sclerosis (MS) in Europe: A European register for MS. Acta Neurol Scand Suppl 2012; 195: 24–30.
5.
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An Expanded Disability Status Scale (EDSS). Neurology 1983; 33: 1444–1452.
6.
Riazi A. Patient-reported outcome measures in multiple sclerosis. Int MS J 2006; 13: 92–99.
1424 http://msj.sagepub.com
Downloaded from msj.sagepub.com at NORTH CAROLINA STATE UNIV on April 21, 2015
research-article2014
MSJ0010.1177/1352458514540844Multiple Sclerosis JournalEditorial
MULTIPLE SCLEROSIS MSJ JOURNAL
Editorial
How useful are MS registries?
Multiple Sclerosis Journal 2014, Vol. 20(11) 1423–1424 DOI: 10.1177/ 1352458514540844
Anthony Traboulsee and Katrina McMullen
© The Author(s), 2014. Reprints and permissions: http://www.sagepub.co.uk/ journalsPermissions.nav
Multiple sclerosis (MS) affects more than two million people worldwide and with a disease onset in early adulthood and long disease duration it has considerable impact on both the individual patient and on society. MS is treatable with disease modifying therapies (DMTs) but so far no cure has been identified, leading to an increasing interest in studying disease characteristics in large populations and observing long term outcomes and treatment monitoring not feasible within the time frames of clinical trials. MS registries may be able to provide this data and different registries and databases exist worldwide.1,2 In this issue of Multiple Sclerosis Journal, Flachenecker et al. present the results of a survey examining the objectives, content and structure of existing European MS registries and how they align with the European Register for MS (EUReMS) project.3,4 This project aims to build on existing registries to create a Europe-wide platform for analysis and comparison of longitudinally acquired MS data in Europe. The present survey revealed that there was a higher number of MS registries than expected (20 identified, 13 participated in the survey and 7 in the structured interview) and despite a considerable number having common objectives that cover at least some of the missions of the EUReMS project, the registries vary from country to country. Across registries, the main objectives were epidemiological research, health care research, long term therapy research and support for clinical trials whilst less frequent aims were cost effectiveness of treatment and quality management of health care. There was also considerable variety in terms of data collection (i.e. hospital versus population based), coverage, organizational structure (i.e. involvement of MS societies), documentation, quality control and governance. Further, fewer than six registries included patient reported outcomes, which have an impact on MS patients, for example employment status, fatigue, bladder/bowel dysfunction, visual disturbances and impairments in social interaction and
cognitive function. These are essential elements of understanding the progression of MS and the efficacy of treatments since clinical endpoints such as Expanded Disability Status Scale (EDSS5) scores are not fully reflective of the experience of the disease.6 Going forward, the EUReMS project aims to integrate the data from existing MS registries across Europe, setting up a standardized data architecture for future data collection and collation of information to provide data that may provide new insights into disease burden, causes and natural history of the disease, long term effectiveness of DMTs, provision of healthcare services and with the inclusion of patient reported outcomes.4
Correspondence to: Anthony Traboulsee University of British Columbia, Faculty of Medicine, Division of Neurology, 2211 Westbrook Mall, Vancouver, BC V6T 2B5, Canada. [email protected] Anthony Traboulsee Katrina McMullen University of British Columbia, Vancouver, Canada
This is an endeavour that requires an enormous amount of effort and commitment to develop, standardize and maintain. What can we hope to gain from a universal but ultimately minimal data set? Realistically we can obtain data that may answer research questions pertaining to epidemiology, healthcare resources and management, and long term efficacy and safety of prescribed treatments. However, it is naïve to assume that a large number of centres contributing to a European registry can provide more than a basic minimal data set. If the goal is to answer questions about the pathogenesis of MS then extensive environmental and genetic information for every patient is necessary but beyond the scope of the pan-European registry. The present survey results highlight that storing data in MS registries is feasible and done in many countries and the overlap between motivations, data collected and data collection methods makes sharing of this information feasible and attractive. We must be overly cautious, however, in how we share the information, in who has access to and who owns and protects the data. At a national level, this is a difficult task; at an international level, it is a gargantuan effort. So is it worth it? That depends on whether there are realistic expectations of what can be obtained from a universal basic data set and the extent
http://msj.sagepub.com 1423
Downloaded from msj.sagepub.com at NORTH CAROLINA STATE UNIV on April 21, 2015
Multiple Sclerosis Journal 20(11) of participation. With extensive participation and commitment to collecting data within standardized protocols, we would have a greater ability to obtain and share information that may shed light on epidemiology, health resources and long term treatment response, aspects of MS that are not observable within the time frames or sample sizes of traditional clinical trials. The rapid increase in MS registries in the last five years reflects an attempt to answer these outstanding questions.
Visit SAGE journals online http://msj.sagepub.com
SAGE journals
Conflict of interest AT has received research support from the MS Society of Canada, Canadian Institute for Health Research, Michael Smith Foundation, holds Steering Committee membership for Hoffmann La Roche and has received consulting fees from MedImmune, Chugai, Roche, Novartis, Biogen, Teva Innovation, EMD Serono. KM has nothing to disclose.
References 1.
Flachenecker P and Stuke K. National MS registries. J Neurol 2008; 255(Suppl. 6): 102–108.
2.
Hurwitz BJ. Registry studies of long-term multiple sclerosis outcomes: Description of key registries. Neurology 2011; 76: S3–S6.
3.
Flachenecker P, Buckow K, Pugliatti M, et al. Multiple sclerosis registries in Europe-results of a systematic survey. Mult Scler 2014; [Epub ahead of print].
4.
Pugliatti M, Eskic D, Mikolcic T, et al. Assess, compare and enhance the status of persons with multiple sclerosis (MS) in Europe: A European register for MS. Acta Neurol Scand Suppl 2012; 195: 24–30.
5.
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An Expanded Disability Status Scale (EDSS). Neurology 1983; 33: 1444–1452.
6.
Riazi A. Patient-reported outcome measures in multiple sclerosis. Int MS J 2006; 13: 92–99.
1424 http://msj.sagepub.com
Downloaded from msj.sagepub.com at NORTH CAROLINA STATE UNIV on April 21, 2015
